Label: DAILY DOSE HYDRA-CERAMIDE BOOST BROAD SPECTRUM SUNSCREEN SPF 40- avobenzone, homosalate, octisalate, octocrylene oil

  • NDC Code(s): 75936-306-01, 75936-306-02, 75936-306-03
  • Packager: Supergoop, LLC
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph final

DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Label Information

Updated October 20, 2022

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  • ACTIVE INGREDIENT

    Active Ingredients Purpose

    Avobenzone 2% Sunscreen

    Homosalate 9% Sunscreen

    Octisalate 5% Sunscreen

    Octocrylene 10% Sunscreen

  • PURPOSE

    Uses

    • Helps prevent sunburn
    • If used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun
  • KEEP OUT OF REACH OF CHILDREN

    • Keep out of reach of children. If product is swallowed, get medical help or contact a Poison Control Center right away.
  • INDICATIONS & USAGE

    Stop use and ask a doctor if rash occurs.

  • WARNINGS

    Warnings

    • For external use only
    • Do not use on damaged or broken skin
    • When using this product keep out of eyes. Rinse with water to remove
  • DOSAGE & ADMINISTRATION

    Directions

    • apply generously and evenly 15 minutes before sun exposure
    • reapply at least every 2 hours
    • Use a water resistant Sunscreen if swimming or sweating
    • Sun Protection Measures Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularly use a sunscreen with a Broad Spectrum SPF value of 15 or higher and other sun protection measures including
    • Limit time in the sun, especially from 10 a.m. - 2 p.m.
    • Wear long-sleeved shirts, pants, hats, and sun glasses
    • Children under 6 months: Ask a doctor
  • INACTIVE INGREDIENT

    Inactive Ingredients Caprylic/Capric Triglyceride, C12-15 Alkyl Benzoate, Dicaprylyl Ether, Butyloctyl Salicylate, Polybutene, Ethyl Olivate, Rosa Canina Seed Oil, Jojoba Oil/ Macadamia Seed Oil Esters, Hydrogenated Polycyclopentadiene, Squalane, Glycine Soja (Soybean) Oil, Simmondsia Chinensis (Jojoba) Seed Oil, Squalene, Polyglyceryl-3 Diisostearate, Tocopherol, Oryza Sativa (Rice) Extract, Oryza Sativa (Rice) Germ Extract, Avena Sativa (Oat) Kernel Oil, Phytosteryl Macadamiate, Ceradmide NP (Ceramide III B), Olea Europaea (Olive) Leaf Extract, Bacillus Ferment, Phytosterols, Ricinus communis (Castor) Seed Oil, Sodium Hyaluronate, Helianthus Annuus (Sunflower) Seed Wax

  • PRINCIPAL DISPLAY PANEL

    Supergoop

    DAILY DOSE

    HYDRA-CERAMIDE BOOST + SPF

    SPF 40

    Broad Spectrum Sunscreen Oil

    SPF 40 PA+++

    1 fl. oz. / 30 ml.

    CartonBottle

  • INGREDIENTS AND APPEARANCE
    DAILY DOSE HYDRA-CERAMIDE BOOST BROAD SPECTRUM SUNSCREEN SPF 40 
    avobenzone, homosalate, octisalate, octocrylene oil
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:75936-306
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE2 g  in 100 mL
    HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE9 g  in 100 mL
    OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE10 g  in 100 mL
    OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE5 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    POLYGLYCERYL-3 DIISOSTEARATE (UNII: 46P231IQV8)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    JOJOBA OIL (UNII: 724GKU717M)  
    BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)  
    ETHYL OLIVATE (UNII: KKJ108Y20W)  
    ROSA CANINA SEED OIL (UNII: MHT97MG5P8)  
    SQUALANE (UNII: GW89575KF9)  
    OLEA EUROPAEA LEAF (UNII: MJ95C3OH47)  
    SOYBEAN OIL (UNII: 241ATL177A)  
    CERAMIDE NP (UNII: 4370DF050B)  
    HELIANTHUS ANNUUS SEED WAX (UNII: 42DG15CHXV)  
    POLYBUTENE (1400 MW) (UNII: 1NA5AO9GH7)  
    SQUALENE (UNII: 7QWM220FJH)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)  
    DICAPRYLYL ETHER (UNII: 77JZM5516Z)  
    CASTOR OIL (UNII: D5340Y2I9G)  
    HYALURONATE SODIUM (UNII: YSE9PPT4TH)  
    OAT KERNEL OIL (UNII: 3UVP41R77R)  
    PHYTOSTERYL MACADAMIATE (UNII: 233VSF903M)  
    RICE GERM (UNII: 7N2B70SFEZ)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:75936-306-011.5 mL in 1 PACKET; Type 0: Not a Combination Product08/26/2021
    2NDC:75936-306-025 mL in 1 BOTTLE; Type 0: Not a Combination Product08/26/2021
    3NDC:75936-306-0330 mL in 1 BOTTLE; Type 0: Not a Combination Product08/26/2021
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart35208/26/2021
    Labeler - Supergoop, LLC (117061743)
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